FDA approves Hikmas liraglutide injection, the first generic form of Novo Nordisks Victoza it has approved.
FDA approves an expanded indication for Rhythms Imcivree to include pediatric patients as young as age 2.
FDA approves Ionis Tryngolza as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome.
FDA says it has completed its evaluation of several adverse effects found in dogs treated with Librela for pain associated with osteoarthritis.
Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating Alzheimers disease ag...
Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compounders.
FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility.
FDA recommends that consumers not purchase or use Rhino 11 gummies due to the presence of undeclared tadalafil.
